(86 days)
Not Found
No
The description focuses on a control material for laboratory assays and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is a control material used for monitoring assay conditions in laboratory tests, not for directly treating a disease or condition in a patient.
No
This device is described as a control material used for monitoring assay conditions in laboratory tests, not for diagnosing specific medical conditions in patients. It helps assure consistent performance of reagents and instruments.
No
The device description explicitly states the product is a liquid stable control material prepared from human serum, indicating it is a physical substance, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for "use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific product is a control material and not directly diagnosing a patient, it is essential for ensuring the accuracy and reliability of diagnostic tests (PTH determinations).
- Device Description: The description states it's a "control material prepared from human serum." Control materials used in clinical laboratories to monitor the performance of diagnostic assays are considered IVDs.
- Care Setting: The intended user is the "clinical laboratory," which is where IVD testing is performed.
- Predicate Device: The mention of a predicate device (K043108; Liquichek ™ Specialty Immunoassay Control) further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
Therefore, the MAS® PTH Control and Moni-Trol® PTH Control are IVD devices because they are used in vitro (outside the body) in a clinical laboratory setting to monitor the performance of diagnostic tests for Parathyroid hormone.
N/A
Intended Use / Indications for Use
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Product codes
JJX
Device Description
This product is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or bodily fluids. Preservatives and stabilizers are added to maintain product integrity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510K SUMMARY
DEC = 3 ""09
109274
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92
The assigned 510(k) number is: TBD
COMPANY/CONTACT PERSON
Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific, Specialty Diagnostics Division, CDx Fremont 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 office (510) 979-5422 fax
DATE PREPARED
August 30, 2009
DEVICE NAME
Trade Names:
MAS® PTH Control Moni-Trol® PTH Control
Common Names:
Liquid Assayed PTH Control
Device Classification: Class I
Classification Panel: Quality Control Material (Assayed and Unassayed) for Clinical Chemistry
Regulation number: 21 CFR 862.1660
Product Code: JJX
INTENDED USE:
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
1
Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE
MAS® PTH Control Moni-Trol® PTH Control is substantially equivalent to the previously cleared Liquichek ™ Specialty Immunoassay Control (K043108)
DESCRIPTION OF DEVICE
This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or bodily fluids. Preservatives and stabilizers are added to maintain product integrity.
| Comparison | Predicate Device, K043108 | Proposed new device |
|---|---|---|
| Intended Use | For use as quality control serum to monitor the precision of laboratory testing procedures listed in the package insert. | MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. |
Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. |
| | Include PTH Control with patient serum
specimens when assaying for
Parathyroid hormones. Assay values
are provided for the specific systems
listed. The user can compare
observations with expected ranges as
means of assuring consistent
performance of reagent and instrument. | |
| Description
of device | This product is
prepared from human
serum with added
constituents,
chemicals, stabilizers,
and preservatives. | This product is a liquid stable control
material prepared from human serum.
Analyte levels are adjusted with various
pure chemicals and preparations from
human tissue or bodily fluids.
Preservatives and stabilizers are added
to maintain product integrity. |
| Matrix | Human Serum | Human Serum |
| Form | Liquid | Liquid |
| Storage
Condition | -20°C to -70°C until
expiration date on the
label | -25°C to -15°C until expiration date on
the label |
| Open Vial
Stability | 30 days at 2-8°C with
exceptions | 30 days when stored tightly capped at
2-8°C |
| Closed Vial
Stability | 30 days at 2-8°C with
exceptions | 90 days when stored tightly capped at
2-8°C |
| Analytes | Anti-Tg
Anti-TPO
C-Peptide
Erythroprotein
Intact PTH
IGF-I
Osteocalcin
25 OH Vitamin D | PTH |
Comparison of Technological Characteristics
2
:
and the comments of the comments of
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
DEC 3 2009
Microgenics Corporation c/o Ms. Lisa Charter Manager, Regulatory affairs Thermo Fisher Scientific Specialty Diagnostics Division, CDx Fremont 4630 Fremont Blvd. Fremont, CA 94538
Re: K092749
Trade/Device Name: MAS® PTH Control and Moni-Trol® PTH Control Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: September 04, 2009 Received: September 08, 2009
Dear Ms. Charter:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);
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Page 2 - Ms. Lisa Charter
labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
ia m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K092749
Device Name:
MAS® PTH Control Moni-Trol® PTH Control
Indication For Use:
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaying for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Prescription Use x (21 CFR Part 801 Subpart D) Subpart C)
And/Or
Over the Counter Use (21 CFR Part 801
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Maria M. Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092749